NCT02072447已完成早期 1 期
A Study to Determine the Absolute Bioavailability of YH4808 Using Simultaneous Oral Therapeutic- and [14C]-Labeled Intravenous Microdoses
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Absolute bioavailability (Fpo)
研究概览
简要总结
This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and [14C]-labeled intravenous microdoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subject aged 20 to 45 at screening
- •subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0
- •subjects who decide to participate voluntarily and write a informed consent form
排除标准
- •subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- •clinically significant allergic disease (except for mild allergic rhinitis)
- •subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
- •subjects considered unsuitable for inclusion by the investigator
研究组 & 干预措施
Microdose
Experimental
干预措施: YH4808 PO and [14C]-YH4808 IV (Drug)
结局指标
主要结局
Absolute bioavailability (Fpo)
时间窗: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48, 96, 144, 216 hours post-dose
次要结局
未报告次要终点
研究者
Howard Lee
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 894416 in the BloodHealthyNCT03722173Boehringer Ingelheim14
已完成
1 期
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a TabletHealthyNCT03783000Boehringer Ingelheim6
已完成
1 期
A Study of LY03005 vs PristiqMajor Depressive DisorderNCT03733574Luye Pharma Group Ltd.56
已完成
1 期
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy ParticipantsHealthy VolunteersNCT04965389Bristol-Myers Squibb17
已完成
1 期
Study of LY3039478 in Healthy ParticipantsHealthyNCT02906618Eli Lilly and Company12